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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
510(k) Number K260063
Device Name GSPE Spacer
Applicant
The General Hospital Corporation, d/b/a Massachusetts
General Hospital
Mgb Innovation Suite 999, 399 Revolution Dr.
Somerville,  MA  02145
Applicant Contact Orhun Muratoglu
Correspondent
Mcra, LLC
803 7th St. NW
Washington,  DC  20001
Correspondent Contact Hollace Rhodes
Regulation Number888.3560
Classification Product Code
JWH  
Subsequent Product Code
MBB  
Date Received01/08/2026
Decision Date 09/11/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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